Inside Health Policy | FDA Inspection Plans Unclear as EUAs Move toward Full Approvals

Cathy Burgess comments on how the U.S. Food and Drug Administration is likely to use remote evaluations to resolve as many issues as possible before returning to onsite inspections of facilities.

Our FDA Team examines the new Executive Order for promoting domestic production of critical medicines and the Food and Drug Administration’s announcement of expanding the use of surprise inspections at foreign manufacturing facilities.

This week, Senate Democrats released draft legislation aimed at preventing labor and delivery unit closures, and CMS announced the upcoming closure of the AAP Program that addressed Medicare funding issues resulting from Change Healthcare cyber-attack.

This week, CMS finalized rules on minimum nursing home staffing standards, as well as access and quality standards in Medicaid, and the Federal Trade Commission (FTC) banned private employers from utilizing most noncompete clauses in employee contracts.

This week, CMS released the FY2025 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Proposed Rule, and Congress held hearings on chronic care and telehealth proposals.